Overall objectives for this contracted effort include research support provided to the National Institute on Drug Abuse (NIDA) Division of Therapeutics and Medical Consequences (DTMC) Regulatory Affairs Branch by providing resources to prepare and submit regulatory submissions for filing with the Food and Drug Administration that are in accordance with The Food and Drug Administration regulations, International Conference on Harmonization guidelines, and Good Clinical Practice guidelines. These submissions may consist of Initial Investigational New Drug applications, New Drug Applications, supplemental New Drug submissions, Annual Reports, information amendments and ad hoc documents as directed by NIDA DTMC.